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A Phase 3 Clinical Study of KHK4827

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01782924
First received: January 27, 2013
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in subjects with moderate to severe plaque psoriasis who have completed the preceding Study 4827-002.


Condition Intervention Phase
Psoriasis
Drug: KHK4827
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: An Extension Study in Subjects With Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • Incidence and types of adverse events and adverse reactions [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory values and vital signs [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Development of anti-KHK4827 antibody [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • sPGA of "clear (0)" [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Body surface area involvement (BSA) of lesion [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Profiles of pharmacokinetics [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Concentration of KHK4827 in serum


Estimated Enrollment: 140
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KHK4827 140mg SC Drug: KHK4827
Experimental: KHK4827 210mg SC Drug: KHK4827

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has voluntarily signed the written informed consent form to participate in this study
  • Subject has completed the week 12 evaluation of Study 4827-002

Exclusion Criteria:

  • Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
  • Subject has been judged to be ineligible for participation in the study by the investigators/subinvestigators
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782924

Locations
Japan
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Chiyoda-ku, Tokyo, Japan, 100-8185
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01782924     History of Changes
Other Study ID Numbers: 4827-003
Study First Received: January 27, 2013
Last Updated: May 15, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 20, 2014